A number of diagnostic and therapeutic procedures require introduction of surgical instruments into the uterus. Some of the procedures involve dilation of the cervix, to facilitate the introduction of the instruments therethrough to the uterus. However, if the cervix is over dilated or patulated or, when a device accessing the uterus is manipulated during a procedure, fluid or gas may leak from the uterus through the cervix. One type of procedure, ablation of uterine tissue to treat endometriosis (e.g., procedures using the Hydro-ThermAblator® (HTA)), may involve the application of intracavity pressure during the introduction of fluids into the uterus.
The treatment of tissue masses (e.g., fibroids and tumors) often involves ablation. For example, a tissue mass may be ablated by inserting a therapeutic device thereinto to apply electrical (RF) energy may to the tissue mass via one or more electrodes or by injecting fluids with appropriate properties into the vicinity of the tissue mass. Tissue masses within the uterus are often treated in this manner, with surgical instruments necessary to carry out the procedure being inserted into the uterus via the cervical canal.
Where the heated or caustic fluids are applied (e.g., to ablate the endometrium), the escape of such fluids from the uterus may damage non-targeted tissues. Although the cervical muscle is strong and effectively creates a seal at the opening of the uterus, procedures such as these may require mechanically enhancing the seal of the cervix around the surgical instruments, to prevent fluid or gas leakage therefrom. Mechanical enhancement of the cervix' seal may also be required where the instruments to be inserted through the cervix require extensive dilation, where the cervix is weak or where significant stresses are exerted against the cervix by movement of the surgical instruments, etc.
The cervix is often sealed during conventional procedures by clamping a tenaculum externally therearound, by wrapping suture loops therearound or by purse string suturing woven in and out of the cervix and drawn tightly to apply compression. Conventional tenaculums include scissor-like clamps that generate significant compression around portions of the cervix. However, multiple clamps may be required to effectively seal the cervix around its entire circumference, and suture loops are not suitable for all patients, as they often require a substantial protrusion of the cervix to enable the loop to lasso therearound. Clamps placed externally to the cervix may also increase trauma and patient discomfort.